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The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS).
The main questions this study aims to answer are:
Researchers will compare a combination of myo-inositol and D-chiro-inositol with a placebo (folic acid alone) to determine whether the combination therapy is more effective in treating PCOS-related menstrual and hormonal abnormalities.
Participants will:
The study will enroll 60 women aged 18-45 years with PCOS at the Department of Obstetrics and Gynecology, Nishtar Hospital Multan. The results may help determine whether myo-inositol and D-chiro-inositol combination therapy is an effective treatment for improving menstrual function and hormonal abnormalities in women with PCOS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myo-Inositol and D-Chiro-Inositol Combination Therapy | Experimental | Participants will receive a combination tablet containing myo-inositol, D-chiro-inositol, and folic acid |
|
| Placebo | Placebo Comparator | Participants will receive folic acid tablets orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-Inositol and D-Chiro-Inositol Combination Therapy | Drug | Participants will receive an oral combination tablet containing myo-inositol (550 mg), D-chiro-inositol (13.8 mg) in a 40:1 ratio, and folic acid (200 µg), taken twice daily for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Menstrual Irregularity | The proportion of participants achieving improvement in menstrual irregularity after treatment. Improvement is defined as restoration of a regular menstrual cycle with an average cycle length of 24-32 days and menstrual blood loss of 21-50 mL per cycle. Menstrual irregularity includes amenorrhea, oligomenorrhea, or menorrhagia assessed through participant menstrual history. | From enrollment to the end of treatment at 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum LH, FSH, and Testosterone levels | Serum FSH, LH, and testosterone concentration measured using venous blood samples collected before treatment and after 3 months of therapy. | At baseline at enrollment to the end of treatment at 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehnaz K Professor, FCPS | Nishtar Medical University and Hospital Multan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishtar Medical University and Hospital Multan | Multan | Punjab Province | 60000 | Pakistan |
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| placebo (folic acid) | Drug | Participants will receive oral folic acid (200 µg) tablets twice daily for 3 months. |
|
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D008599 | Menstruation Disturbances |
| D009839 | Oligomenorrhea |
| D000568 | Amenorrhea |
| D008595 | Menorrhagia |
| D017588 | Hyperandrogenism |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D006470 | Hemorrhage |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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